Job Description
Our client is seeking a Senior Process Engineer with substantial downstream manufacturing experience. They are currently supporting clinical supply for two products and need to expand their manufacturing footprint. This candidate will act as the Person in Plant (PIP) during CDMO site visits and will provide audit and manufacturing readiness support. They will provide technical input during cell line development, early and late-stage process development, technology transfer, process improvement, and manufacturing. This includes participation in recurring meetings, data analysis, troubleshooting, and review of documentation (batch records, protocols, reports, event records, etc.). The ideal candidate will have a minimum of 10 years in biologic manufacturing or process development, excellent communication skills, Downstream equipment (Chromatography, filtration, etc..), and project management skills to provide organized updates throughout the project.
Required Skills
Provide technical support of process development and manufacturing at Drug Substance CDMOs
Review batch records, process and analytical data, technical reports, and stability data
Analyze process data and summarize in presentations and project dashboards
Author SOPs, technical protocols, and reports
Serve as Person-In-Plant (PIP) at CDMOs for critical manufacturing activities
Contribute to the authoring of Investigational New Drug applications (INDs), IND annual updates, Biologics Licensing Applications (BLAs) and other regulatory submissions
Present data and program updates at internal and external meetings
Hybrid (Remote w/CDMO sites visits): Sr. Process Engineer- (232450)
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